A Phase 2 interventional study of Mifepristone 1200 mg daily and Standardized behavioral therapy in Alcohol Dependence, Alcohol Use Disorders and Alcohol Abuse, sponsored by The Scripps Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-10-06.
Sponsored by The Scripps Research Institute · Phase 2, Interventional, and Treatment
This is an 8-week, randomized, double-blind, placebo-controlled, 2 arm, parallel groups, study of 1-week of treatment with mifepristone (0, 1200 mg/d) given in conjunction with 8 weeks of manual-guided counseling, and a follow-up visit at Week 12.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 103 is above the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →The Scripps Research Institute is the lead sponsor of 19 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
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Exclusion Criteria:
1200 mg mifepristone daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy
Drug: Mifepristone 1200 mg daily · Behavioral: Standardized behavioral therapy
Placebo pills daily for 1-week given in conjunction with 8 weeks of standardized behavioral therapy
Behavioral: Standardized behavioral therapy · Drug: Placebo
Mifepristone, 300 mg tablets, Four tablets daily/am for 1-week duration.
Also known as: Korlym
Standardized behavioral therapy 1 time per week for 8 week duration.
Also known as: Manually-guided therapy
Placebo tablets, Four tablets daily/am for 1-week duration.
Also known as: Placebo Comparator
Drinking Quantity Per Day
Drinking quantity in standard drinks per day is measured by the Timeline Followback interview. A standard drink contains 14 grams of alcohol, e.g., 1.5 ounces of distilled spirits, 5 ounces of wine, or 12 ounces of beer.
Time frame: Participants will be followed for up to 12 weeks post-assignment
Craving
Alcohol Craving Questionnaire; minimum value equals 12, maximum value equals 84; higher scores mean greater craving for alcohol.
Time frame: Participants will be followed for up to 12 weeks
Subjects were recruited for study participation at the Laboratory of Clinical Psychopharmacology at The Scripps Research Institute in La Jolla, CA from 10/13/2014-11/6/2019. One Hundred three subjects were enrolled, One Hundred one subjects completed 1-week of medication/placebo, Ninety subjects completed 8-weeks of counseling, and Eighty-four subjects completed a 12-week follow up visit.
| Milestone | Experimental: Mifepristone 1200 mg Daily | Placebo Daily, 1-week | Experimental: Mifepristone 600 mg Day |
|---|---|---|---|
| Started | 49 | 32 | 22 |
| Completed | 49 | 32 | 20 |
| Not completed | 0 | 0 | 2 |
| Withdrew: Adverse event | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 |
Drinking quantity in standard drinks per day is measured by the Timeline Followback interview. A standard drink contains 14 grams of alcohol, e.g., 1.5 ounces of distilled spirits, 5 ounces of wine, or 12 ounces of beer.
| Standard drinks per day | Placebo | 600 mg/d of Mifepristone | 1200 mg/d of Mifepristone |
|---|---|---|---|
| Drinking Quantity Per Day | 1.25 ± 0.21 | 1.38 ± 0.21 | 1.10 ± 0.21 |
Alcohol Craving Questionnaire; minimum value equals 12, maximum value equals 84; higher scores mean greater craving for alcohol.
| score on a scale | Experimental: Mifepristone 1200 mg Daily | Placebo Daily, 1-week | Experimental: Mifepristone 600 mg Day |
|---|---|---|---|
| Craving | 29.02 ± 36.69 | 33.66 ± 36.69 | 28.33 ± 36.69 |
Collected over Study medication was administered for one week. Adverse event data were collected during this 1-week of medication or placebo treatment. These treatment emergent adverse events were followed until resolution over the 8-week behavioral therapy period.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental: Mifepristone 1200 mg Daily | 0/49 (0%) | 0/49 (0%) | 17/49 (34.7%) |
| Placebo Daily, 1-week | 0/32 (0%) | 1/32 (3.1%) | 8/32 (25%) |
| Experimental: Mifepristone 600 mg Day | 0/22 (0%) | 0/22 (0%) | 2/22 (9.1%) |
| Event | Experimental: Mifepristone 1200 mg Daily | Placebo Daily, 1-week | Experimental: Mifepristone 600 mg Day |
|---|---|---|---|
| SyncopeNervous system disorders | 0/49 | 1/32 | 0/22 |
| Event | Experimental: Mifepristone 1200 mg Daily | Placebo Daily, 1-week | Experimental: Mifepristone 600 mg Day |
|---|---|---|---|
| HeadacheNervous system disorders | 12/49 | 4/32 | 2/22 |
| FatiguePsychiatric disorders | 5/49 | 4/32 | 0/22 |
| Age, Continuous(years) | Experimental: Mifepristone 1200 mg Daily | Placebo Daily, 1-week | Experimental: Mifepristone 600 mg Day | Total |
|---|---|---|---|---|
| Mean | 46.9 ± 11.0 | 46.4 ± 11.9 | 44.4 ± 12.3 | 46.2 ± 11.5 |
| Sex: Female, Male(Participants) | Experimental: Mifepristone 1200 mg Daily | Placebo Daily, 1-week | Experimental: Mifepristone 600 mg Day | Total |
|---|---|---|---|---|
| Female | 17 | 13 | 8 | 38 |
| Male | 32 | 19 | 14 | 65 |
| Ethnicity (NIH/OMB)(Participants) | Experimental: Mifepristone 1200 mg Daily | Placebo Daily, 1-week | Experimental: Mifepristone 600 mg Day | Total |
|---|---|---|---|---|
| Hispanic or Latino | 10 | 8 | 4 | 22 |
| Not Hispanic or Latino | 39 | 24 | 18 | 81 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Experimental: Mifepristone 1200 mg Daily | Placebo Daily, 1-week | Experimental: Mifepristone 600 mg Day | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 1 | 3 |
| Asian | 2 | 0 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 3 | 0 | 0 | 3 |
| White | 38 | 27 | 17 | 82 |
| More than one race | 4 | 4 | 2 | 10 |
| Unknown or Not Reported | 1 | 0 | 1 | 2 |
| Region of Enrollment(participants) | Experimental: Mifepristone 1200 mg Daily | Placebo Daily, 1-week | Experimental: Mifepristone 600 mg Day | Total |
|---|---|---|---|---|
| United States | 49 | 32 | 22 | 103 |
| DSM-V symptom count(symptoms) | Experimental: Mifepristone 1200 mg Daily | Placebo Daily, 1-week | Experimental: Mifepristone 600 mg Day | Total |
|---|---|---|---|---|
| Mean | 8.63 ± 1.53 | 8.22 ± 1.99 | 8.59 ± 2.30 | 8.5 ± 1.86 |
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